Denkin, StevenBhatia, SujataMachado, Terra Leonie2023-05-0220232023-05-012023Machado, Terra Leonie. 2023. Nanoparticle Clearance: A Regulatory Summary Recommending Strengthening of the Current FDA Guidance in Assuring Long Term Safety of Nanoparticle Therapies in Cancer Patients. Master's thesis, Harvard University Division of Continuing Education.30485640https://nrs.harvard.edu/URN-3:HUL.INSTREPOS:37375025Cancer has complicated pathogenesis, making it one of the leading causes of mortality and morbidity. Traditional cancer treatments include targeted therapy, immunotherapy, chemotherapy, and radiation therapy. The development of nanotechnology has led to a revolution in the treatment and detection of cancer. Nanoparticles can be a better option for cancer because they have unique advantages like biocompatibility, less drug related toxicity, better stability, higher permeability and retention impact, and precise targeting. This overview discusses the factors that could affect the biodistribution and blood circulation half-life of nanoparticles (NPs) used in drug delivery systems. These variables include adjustable nanoparticle parameters such as composition, size, core characteristics, surface modifications like PEGylation and surface charge, targeted ligand functionalization, and interactions with biological barriers. Cancer currently presents a challenge to effective treatment due to its complicated pathogenesis and the drawbacks of traditional treatments such as multi-drug resistance, cytotoxicity, and lack of selectivity. Nanoparticles have unique advantages such as biocompatibility, less toxicity, better stability, higher permeability and retention effect, and precise targeting. Furthermore, drug delivery systems based on nanoparticles can help reduce cancer-related treatment resistance, which is caused by impaired apoptotic pathways, overexpression of drug efflux transporters, and hypoxic environments. Nanoparticles are also being investigated for their potential use in immunotherapy. This overview examines how NPs can be utilized to deliver drugs, how they are cleared from the body, and proposes how the FDA has set guidance for the industry for nanomaterials and the gaps for where they can do more to keep these therapies safe for use in humansapplication/pdfenNanotechnologyThesis or Dissertation2023-05-02